Aim
Clinical Trial Document Management: A Hands-On Course teaches how clinical trial documents are created, filed, tracked, and audited across the trial lifecycle. Learn essential documents, TMF basics, version control, QC checks, and inspection readiness.
Program Objectives
- Trial Documentation: core documents from start-up to close-out.
- TMF Basics: structure, filing, and completeness checks.
- Document Control: versions, approvals, and templates.
- Quality: QC, ALCOA+ concepts, and audit trails.
- Systems: eTMF, metadata, naming, and workflows.
- Compliance: GCP documentation expectations (overview).
- Capstone: build a mini eTMF with QC and tracker.
Program Structure
Module 1: Clinical Trial Documentation Overview
- Why documentation matters: quality, safety, compliance.
- Trial lifecycle: start-up, conduct, close-out.
- Document roles: sponsor, CRO, site, monitors.
Module 2: Essential Documents (Start-Up)
- Protocol, IB, ICF basics (overview).
- Feasibility, site selection, and contracts (intro).
- Regulatory submissions and approvals (overview).
- Training logs and delegation logs (overview).
Module 3: Trial Conduct Documents
- Monitoring reports, visit letters, follow-up actions.
- Safety documentation links: SAE reporting flow (overview).
- IP accountability, temperature logs (overview).
- Protocol deviations and CAPA documentation.
Module 4: TMF and Filing Standards
- TMF structure and filing logic (overview).
- Indexing, metadata, naming conventions.
- Completeness checks and reconciliation.
- Common filing errors and fixes.
Module 5: Document Control and Version Management
- Templates, authoring, review, and approval cycles.
- Change control and version history.
- Signatures: wet ink vs e-sign (overview).
- Archiving and retention basics.
Module 6: QC, Audit Trails, and Inspection Readiness
- QC checklist: completeness, legibility, accuracy.
- ALCOA+ concepts for data integrity (intro).
- Audit trails and access control basics.
- Inspection readiness: how to respond and what to show.
Module 7: eTMF Operations (Hands-On)
- Uploading, indexing, and workflow routing (overview).
- Queries, re-filing, and rework cycles.
- Dashboards: completeness, timeliness, quality (overview).
- Building a document tracker and status reporting.
Module 8: Close-Out and Archival
- Close-out documents and final reconciliation.
- Final TMF review and QC summary.
- Archival, retention, and retrieval basics.
- Lessons learned and continuous improvement.
Final Project
- Create a mini TMF/eTMF structure for a sample study.
- Deliverables: document list + tracker + naming rules + QC checklist.
- Submit: mini eTMF pack + short summary report.
Participant Eligibility
- Pharmacy, Life Sciences, Biotechnology, Clinical Research students/professionals
- CRAs, CTA/CTM trainees, document specialists
- Basic GCP awareness helpful
Program Outcomes
- Identify and manage essential clinical trial documents.
- Organize files using TMF structure and naming standards.
- Apply version control, QC checks, and inspection readiness basics.
- Build a document tracker and a mini eTMF pack.
Program Deliverables
- e-LMS Access: templates, trackers, sample documents.
- Toolkit: TMF checklist, QC checklist, naming convention guide, tracker sheet.
- Assessment: certification after capstone submission.
- e-Certification and e-Marksheet: digital credentials.
Future Career Prospects
- Clinical Trial Assistant (CTA)
- TMF/eTMF Specialist
- Clinical Documentation Associate
- Study Start-Up Coordinator
Job Opportunities
- CROs/Sponsors: TMF, clinical operations, document control teams.
- Hospitals/Research Sites: study coordinator and regulatory file roles.
- Pharma/Biotech: clinical trial documentation and compliance roles.
- Consulting: TMF remediation and inspection readiness support.
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